vitamin d deficiency, muscle pain, joint pain, and joint stiffness in postmenopausal women receiving letrozole for stage i-iii breast cancer

Conditions: Arthralgia; Musculoskeletal Complications; Pain; Recurrent Breast Cancer; Stage I Breast Cancer; Stage II Breast Cancer; Stage IIIA Breast Cancer; Stage IIIB Breast Cancer; Stage IIIC Breast Cancer

Summary: this phase ii trial is studying vitamin d deficiency, muscle pain, joint pain, and joint stiffness in postmenopausal women receiving letrozole for stage i-iii breast cancer. learning about vitamin d deficiency and muscle pain, joint pain, and joint stiffness in patients receiving letrozole for breast cancer may help doctors plan treatment and may help patients live more comfortably

primary objectives: i. to assess the rate of vitamin d deficiency in breast cancer patients who experience myalgias, arthralgias and/or joint stiffness following initiation of adjuvant letrozole treatment. secondary objectives: i. to determine if there is a correlation between letrozole serum levels and the development of myalgias, arthralgias and/or joint stiffness. ii. to assess if vitamin d supplementation may alleviate myalgias, arthralgias and/or joint stiffness associated with letrozole in those subjects with vitamin d deficiency. outline: patients receive letrozole orally (po) once daily (qd). patients, who experience muscle pain, joint pain, or joint stiffness that requires an intervention and who are found to be vitamin d deficient, also receive calcium po and vitamin d3 po. treatment continues for up to 28 weeks in the absence of disease progression or unacceptable toxicity.

Eligibility criteria:
inclusion criteria: * patients must have a histologically confirmed diagnosis of stage i, ii or iii breast carcinoma * patients must be prescribed letrozole for adjuvant breast cancer treatment * prior adjuvant tamoxifen is permitted * patients must be postmenopausal; for study purposes, postmenopausal is defined as: a prior documented bilateral oophorectomy, or a history of at least 12 months without spontaneous menstrual bleeding, or have a persistently postmenopausal estradiol in the past 6 months without menses, and clinically in menopause at the judgment of the treating physician, or age 60 or older with a prior hysterectomy without oophorectomy, or age less than 60 with a prior hysterectomy without oophorectomy (or in whom the status of the ovaries is unknown), with a documented fsh level demonstrating confirmatory elevation in the postmenopausal range for the lab exclusion criteria: * diagnosis of stage iv breast carcinoma * pre-existing myalgias, arthralgias and/or joint stiffness \>= grade 1, as defined using ctep ctc identified during baseline physical exam * inability to understand or cooperate with study procedures * receipt of investigational drug within 30 days before study entry * lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome * unwillingness to give informed consent * unwillingness to participate or inability to comply with the protocol for the duration of the study * patients with serum calcium \>= 14 mg/dl * patients with renal dysfunction defined as glomerular filtration rate \<10ml/min calculated using cockroft-gault equation